510(k) K981524
K981524 is an FDA 510(k) premarket notification submitted by Gresco Products, Inc. for the device "PRILANE". The FDA issued a decision of Substantially Equivalent on July 10, 1998. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Gresco Products, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1998
- Date Received
- April 28, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type